Market Newsdesk

HAIFA, Israel, Sept. 22, 2021 (GLOBE NEWSWIRE) — Pluristem Therapeutics Inc. (Nasdaq: PSTI) (TASE: PSTI), a leading biotechnology company, today issued an update to its shareholders from its Chief Executive Officer and President Yaky Yanay.

Dear Shareholders,

Less than three months into a new fiscal year, there are several important developments on the horizon for Pluristem, including four studies heading to clinical readout in the coming quarters. These studies align with our mission to develop novel cell therapy product candidates, built using Pluristem’s advanced technology.

Clinical Pipeline: Milestones

During the coming year, we expect to meet multiple clinical milestones, which represent significant potential for our cellular platform.

First, our Phase I study evaluating PLX-R18 cells in subjects with incomplete hematopoietic recovery following Hematopoietic Cell Transplantation (HCT) demonstrated positive topline results as reported in April 2021, and we expect to present full data readout in the fourth quarter of this calendar year. We also expect to continue the development of the program and to initiate a Phase II study in hematological indication. Second, we expect topline results in the fourth quarter of this calendar year for both of our Phase II studies of PLX-PAD cells to treat acute respiratory distress syndrome (ARDS) associated with COVID-19 in the U.S., Europe, and Israel. Third, our Phase III study evaluating PLX-PAD cells to support muscle regeneration after hip fracture surgery has enrolled more than 95 percent of its patients and is expected to complete enrollment in October 2021.

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/d88b55bc-a12f-4421-ad52-adca69bf0b5d

Strategic Plan: Platform Expansion

In the last decade, we have developed an automated and robust current Good Manufacturing Practice (cGMP) manufacturing platform for allogeneic cells originating from the fetal and maternal cells from the placenta. Using this platform, we can produce large quantities of high-quality cells suitable for a variety of applications and uses. The manufacturing platform enables us to develop targeted pipelines of cellular product candidates including induced or modified PLX cells:

Induced PLX cells: These cells from the placenta are induced with different cytokines to transiently alter their secretion profile. Our first product candidate under this technology is PLX-R18. The positive data presented in the hematology study in April 2021 supports our approach of targeting cells with superior activity per indication. We expect to continue developing this platform for inducing cells and are in advanced development to complete additional targeted product candidates of this nature.

Modified PLX cells using CRISPR technology: We are also working on integrating CRISPR’s revolutionary genetic engineering technology to potentially engineer PLX cells with novel and targeted functionality. Combined with our placenta-derived cell manufacturing platform, Pluristem would use CRISPR technology to potentially develop a new class of ex vivo modified allogenic PLX cell therapy product candidates to address new indications.

In short, we have developed a reliable, stable, and cost-effective cell expansion platform. We believe that using the placenta as a unique cell source combined with our innovative research, development, and high-quality manufacturing capabilities will be the engine that drives this platform technology towards the successful development of additional PLX cell therapy product candidates and indications.

We are excited to continue developing the powerful therapeutic capabilities of placental cells while using our advanced technology to push boundaries.

Summary: Key Competitive Advantage

What is Pluristem’s biggest advantage? Our talented management team and I asked this question in recent months as part of our five-year strategic discussions. The outcome is clear: Develop effective and innovative cellular product candidates while assuring manufacturing capacity on the back end when the product candidate is ready for market. We believe that this is our defining competitive advantage. Over the years, we have received interest from potential partners to use our platform for pharmaceuticals and other industries. Pluristem intends to use its unmatched technological advantage to establish mutually advantageous partnerships towards the best utilization and optimization of our assets for the benefit of our shareholders.

Sincerely,

Yaky Yanay
CEO & President

About Pluristem Therapeutics

Pluristem is pushing the boundaries of science and engineering to reimagine pharmacological treatments and improve the standard of care. The Company’s cell therapies advance the field of regenerative medicine, with potentially groundbreaking applications for treating damaged muscle, hematology deficiencies, and inflammation. Pluristem sources its therapeutic cells from the placenta, an ethically accepted and potent source. Cells are easy to collect and do not require blood or tissue matching. Cells from one placenta can treat 20,000 patients. The Company’s manufacturing platform, the bioreactor, is a patented and validated state-of-the-art 3D cell expansion system, designed to mimic the human body. Pluristem’s method is uniquely accurate, cost-effective, and consistent batch-to-batch.

Safe Harbor Statement

This press release contains express or implied forward-looking statements within the Private Securities Litigation Reform Act of 1995 and other U.S. Federal securities laws. For example, Pluristem is using forward-looking statements when it discusses the expected timing of the topline results from its Phase II studies of PLX-PAD cells to ARDS associated with COVID-19 and the presentation of the full data readout of the HCT Phase I study evaluating PLX-R18 cells, the expected completed enrollments in its Phase III study evaluating PLX-PAD cells to support muscle regeneration after hip fracture surgery, its expectation that it will continue the development of its platform for inducing cells and is in advanced development to complete additional targeted product candidates of this nature, its intention to use CRISPR technology to potentially develop a new class of ex vivo modified allogenic PLX cell therapy product candidates to address new indications and that it intends to use its technological advantage to establish mutually advantageous partnerships towards the best utilization and optimization of its assets. These forward-looking statements and their implications are based on the current expectations of the management of Pluristem only and are subject to several factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; Pluristem may encounter delays or obstacles in launching and/or successfully completing its clinical trials; Pluristem’s products may not be approved by regulatory agencies, Pluristem’s technology may not be validated as it progresses further and its methods may not be accepted

by the scientific community; Pluristem may be unable to retain or attract key employees whose knowledge is essential to the development of its products; unforeseen scientific difficulties may develop with Pluristem’s process; Pluristem’s products may wind up being more expensive than it anticipates; results in the laboratory may not translate to equally good results in real clinical settings; results of preclinical studies may not correlate with the results of human clinical trials; Pluristem’s patents may not be sufficient; Pluristem’s products may harm recipients; changes in legislation may adversely impact Pluristem; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem’s reports filed from time to time with the Securities and Exchange Commission.

Contact:

Dana Rubin
Director of Investor Relations
+972-74-7107194
[email protected]

TEL AVIV, Israel, Sept. 22, 2021 (GLOBE NEWSWIRE) — via InvestorWire — Save Foods (Nasdaq: SVFD) (“Save Foods” or the “Company”), an agrifood tech company focused on developing and selling eco-friendly products specifically designed to extend the shelf life and ensure food safety of fresh fruits and vegetables, today announced that it successfully completed a series of lemon treatment pilot tests in Spain, with a leading post-harvest service provider (“the Provider”).

Spain is the leading European country in terms of lemon production, with a total of 1.2 million tons in 2020; that is 64% of the EU’s total lemon production. Spain is the largest lemon exporter in the world, accounting for approximately 27% with an estimated market value of $1 billion in 2020.

The pilots, which are part of the Company’s strategy targeting the EU as a prime market, were designed to evaluate the efficacy of Save Foods’ products in controlling some of the main post-harvest plant diseases as well as reducing the use of fungicides which leave residue, such as Imazalil. The tests were specifically designed to meet the anticipated increase in EU regulatory restrictions with respect to the allowable levels of residual fungicide.

The Provider that participated in the pilot indicated to Save Foods that preliminary results met the established milestones. As a result, the Company and Provider are discussing plans for a commercial-grade validation test to take place in the upcoming harvest season.

The EU has some of the most aggressive regulations in the world regarding the sale of fruits and vegetables within its borders. Its Farm to Fork Strategy, which is at the heart of the European Green Deal Initiative, sets definitive benchmarks to reduce pesticides use by 50% and fertilizer use by 20%, and transition 25% of all EU farmland into organic cultivations by 2030. Some food retailers in member countries, like in Germany, have gone beyond the Farm to Fork Strategy, creating their own, narrower regulations.

Dan Sztybel, Chief Executive Officer of Save Foods Ltd., the Company’s Israeli subsidiary, commented on the announcement, “The successful lemon tests confirm the results we’ve repeatedly demonstrated in other independent tests and commercial applications. We will continue to work with our partners in the upcoming harvest season to further validate Save Foods’ treatments on lemons and other citrus fruits.”

Sztybel went on, “I believe the results we achieved in these pilots support our marketing efforts in the EU, where increasingly stringent regulations will make compliance difficult for operators and exporters. Our green treatments provide a seamless solution for packers to meet those regulations with no compromise to their fruit quality or shelf life.”

David Palach, Chief Executive Officer of the Company, commented, “I truly appreciate the EU’s proactive approach to food safety, reducing waste, limiting the use of pesticides and other contaminants, and promoting a sustainable food system. They are taking a big step toward safeguarding the EU’s food supply as well as the environment. I’m hopeful the Farm to Fork Strategy will serve as an example for other world markets.”

About Save Foods

Save Foods is an innovative, dynamic company addressing two of the most significant challenges in the agrifood tech industry: food waste & loss and food safety. Save Foods is dedicated to delivering integrated solutions for improved safety, freshness and quality, every step of the way from field to fork. Collaborating closely with its customers, Save Foods develops new solutions that benefit the entire supply chain and improve the safety and quality of life of both the workers and the consumers alike. Save Foods’ initial applications are in post-harvest treatments in fruit and vegetable packing houses processing citrus, avocado, pears, bell peppers and mangos. By controlling and preventing pathogen contamination and significantly reducing the use of hazardous chemicals and their residues, Save Foods’ products not only prolong fresh produce shelf life and reduce food loss and waste, but they also ensure a safe, green and healthy product.

For more information visit our website at https://savefoods.co/

Forward-Looking Statements


This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995 and other Federal securities laws. Words such as “expects,” “anticipates,” “intends,” “plans,” “believes,” “seeks,” “estimates” and similar expressions or variations of such words are intended to identify forward-looking statements. For example, we are using forward-looking statements in this press release when we discuss our ability to penetrate the EU markets, the far-reaching positive ramifications of the results of the pilot test held in Spain as discussed in this press release, the ability of our products to effectively address and comply with each of the newly enacted EU regulations, that our products may effectively enable packers to meet EU regulatory requirements for regulations discussed in this press release, that our proprietary blend of organic food acids may reduce the need for conventional post-harvest fungicide by at least 50% and in some cases entirely and may reduce food waste due to spoilage by up to 50% and when we discuss the continuing demand for a safe, high quality, sustainable food supply. Actual results, performance, or achievements could differ materially from those described in or implied by the statements in this press release. The forward-looking statements contained or implied in this press release are subject to other risks and uncertainties, including market conditions and the satisfaction of all conditions to, and the closing of, the offering, as well as those discussed under the heading “Risk Factors” in Save Foods’ annual report on Form 10-K filed with the SEC on March 29, 2021, and in any subsequent filings with the SEC. Except as otherwise required by law, we undertake no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. References and links to websites have been provided as a convenience, and the information contained on such websites is not incorporated by reference into this press release. We are not responsible for the contents of third-party websites.

Media Contact:
Dariela Farcas
[email protected]

Corporate Communications:

InvestorBrandNetwork (IBN)
Los Angeles, California
www.InvestorBrandNetwork.com
310.299.1717 Office
[email protected]

–


TMB-302 study results demonstrate that there was no difference in pharmacokinetics between IV Push and IV Infusion –

– No serious adverse events observed –

– sBLA filing planned for Q4 2021 –

MONTREAL, Sept. 22, 2021 (GLOBE NEWSWIRE) — Theratechnologies Inc. (Theratechnologies, or Company) (TSX: TH) (NASDAQ: THTX), a biopharmaceutical company focused on the development and commercialization of innovative therapies, is pleased to announce that a study evaluating an intravenous (IV) push form of administration of Trogarzo^® for the treatment of human immunodeficiency virus type 1 (HIV-1) infection achieved consistent and statistically significant results demonstrating that there was no difference in pharmacokinetics (PK) between IV Push and IV Infusion. Based on these results, a supplemental Biologics License Application (sBLA) is expected to be filed with the U.S. Food and Drug Administration (FDA) in the fourth quarter of 2021.      

The TMB-302 study was conducted by the Company’s partner, TaiMed Biologics (TaiMed), to evaluate the safety and comparability of the current Trogarzo^® IV Infusion mode of administration with a more convenient IV Push form of administration that can be infused within 30 seconds without dilution compared to the 15-minute infusion time of the original IV Infusion.   

“These results confirm that the IV Push method of administration of Trogarzo^® is an effective alternative to the current IV Infusion administration,” said Paul Levesque, President and Chief Executive Officer of Theratechnologies. “This more convenient IV Push mode of administration also offers patients a rapid infusion time and requires only two quick infusions per month. We are confident that this faster infusion may further increase patient compliance, allowing patients to benefit from long-acting protection against HIV-1 when Trogarzo^® is administered with other antiretrovirals.”  

The primary endpoint measuring a 90% confidence interval of the ratio of IV Push to IV Infusion was within the target value. The proportion of subjects with mean trough serum drug concentration equal or exceeding the target concentration was also the same for both forms of administration. Additionally, there were no serious adverse events observed and drug-related adverse events were considered mild to moderate.

Secondary endpoints were also achieved confirming no difference in HIV-1 viral load due to the change from IV Infusion to IV Push. Additionally, there were no anti-Trogarzo^® antibodies or immunogenicity concerns of Trogarzo^® detected.

Theratechnologies and TaiMed are currently evaluating an intramuscular (IM) method of administration for Trogarzo^® as part of the TMB-302 study with patient screening planned for the fourth quarter of 2021.   The study will be conducted and funded by Theratechnologies with support from TaiMed.

Under the terms of the agreement with TaiMed, Theratechnologies is entitled to commercialize the new IV Push and IM methods of administration of Trogarzo^® if, and when, approved.  

About Trogarzo

^®


Trogarzo® is a CD4-directed post-attachment HIV-1 inhibitor. Trogarzo® is approved for commercialization in the United States and in the European Union. In the United States, Trogarzo®, in combination with other antiretroviral(s), is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in heavily treatment-experienced adults with multidrug resistant HIV-1 infection failing their current antiretroviral regimen.

About Theratechnologies

Theratechnologies (TSX: TH) (NASDAQ: THTX) is a biopharmaceutical company focused on the development and commercialization of innovative therapies addressing unmet medical needs. Further information about Theratechnologies is available on the Company’s website at www.theratech.com, on SEDAR at www.sedar.com and on EDGAR at www.sec.gov

Forward-Looking Information

This press release contains forward-looking statements and forward-looking information, or, collectively, forward-looking statements, within the meaning of applicable securities laws, that are based on our management’s beliefs and assumptions and on information currently available to our management. You can identify forward-looking statements by terms such as “may”, “will”, “should”, “could”, “would”, “outlook”, “believe”, “plan”, “envisage”, “anticipate”, “expect” and “estimate”, or the negatives of these terms, or variations of them. The forward-looking statements contained in this press release include, but are not limited to, statements regarding the filing of an sBLA with the FDA and the timing of such filing, the convenience of the IV Push method of administration, the increase in patient compliance and seeking approval of the IV Push mode of administration, the development of the IM method of administration for Trogarzo^® and the timelines to initiate same.

Although the forward-looking information contained in this press release is based upon what the Company believes are reasonable assumptions in light of the information currently available, investors are cautioned against placing undue reliance on this information since actual results may vary from the forward-looking information. Certain assumptions made in preparing the forward-looking statements include that: the current COVID-19 pandemic will have limited adverse effect on the Company’s operations; sales of Trogarzo^® in the United States and Europe will increase over time; the IV Push method of administration will be approved by the FDA and, if approved, will be accepted by the marketplace; the long-term use of Trogarzo^® will not change its safety profile; no recall or market withdrawal of Trogarzo^® will occur; no laws, regulation, order, decree or judgment will be passed or issued by a governmental body negatively affecting the marketing, promotion or sale of Trogarzo^® in countries where such products are commercialized; continuous supply of Trogarzo^® will be available; the timelines set forth in this press release will be met; the Company’s relations with third-party suppliers of its products will be conflict-free and such third-party suppliers will have the capacity to manufacture and supply the Company’s products to meet market demand on a timely basis; and the Company’s business plan will not be substantially modified.

Forward-looking information assumptions are subject to a number of risks and uncertainties, many of which are beyond Theratechnologies’ control that could cause actual results to differ materially from those that are disclosed in or implied by such forward-looking information. These risks and uncertainties include, but are not limited to, those related to or arising from: the adverse impact of the COVID-19 pandemic on (a) the Company’s sales efforts and sales initiatives, (b) the capacity of the Company’s suppliers to meet their obligations vis-à-vis the Company, (c) the Company’s research and development activities, (d) the health of the Company’s employees and its capacity to rely on its resources, as well as (e) global trade; the non-approval by the FDA of the IV Push method of administration; delays in filing the sBLA seeking approval of the IV Push method of administration and delays in initiating the development of the IM method of administration for Trogarzo^® as part of the TMB-302 study; the Company’s ability and capacity to grow the sales of Trogarzo^® successfully in the United States and in Europe; the Company’s capacity to meet supply and demand for its products; the market acceptance of the IV Push method of administration of Trogarzo^®, if and when approved, in the United States; the Company’s expectations regarding its financial performance, including revenues, expenses, gross margins, profitability, liquidity, capital expenditures and income taxes; and the Company’s estimates regarding its capital requirements.

We refer current and potential investors to the “Risk Factors” section of our Annual Information Form dated February 24, 2021 available on SEDAR at www.sedar.com and on EDGAR at www.sec.gov as an exhibit to our report on Form 40-F dated February 25, 2021 under Theratechnologies’ public filings. The reader is cautioned to consider these and other risks and uncertainties carefully and not to put undue reliance on forward-looking statements. Forward-looking statements reflect current expectations regarding future events and speak only as of the date of this press release and represent our expectations as of that date.

We undertake no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise, except as may be required by applicable law.

For media and investor inquiries:

Leah Gibson
Senior Director, Investor Relations
[email protected]
617-356-1009

MARLBOROUGH, Mass., Sept. 22, 2021 (GLOBE NEWSWIRE) — Akoya Biosciences, Inc. (NASDAQ: AKYA) (“Akoya”), The Spatial Biology Company®, today announced the appointment of Myla Lai-Goldman, MD, a true pioneer and leader in the diagnostic industry, to its board of directors.

“It is an honor to join the board of Akoya, a company that is providing innovative spatial biology solutions with the potential to transform the life sciences market,” said Dr. Lai-Goldman. “Akoya’s platforms provide an unprecedented capability to understand the relationship of cells to their tumor microenvironment, and span applications from discovery and clinical research. The groundbreaking discoveries emanating from this work could dramatically increase our understanding of patient response to therapy and ultimately improve standard of care.”

Dr. Lai-Goldman has extensive experience in all aspects of the diagnostics industry. From 1990 to 2008, Dr. Lai-Goldman held various roles including Executive Vice President, Chief Medical Officer and Chief Scientific Officer at Laboratory Corporation of America Holdings (LabCorp) and its predecessor company, Roche Biomedical Laboratories, Inc. During her tenure at LabCorp, she led all clinical, scientific, and medical activities, including the introduction of more than 400 clinical assays. Her experience includes the development of partnerships, licensing, and acquisitions. Dr. Lai‐Goldman is currently the Chair of GeneCentric Therapeutics, a precision medicine company, which she co-founded and previously served as CEO and President. She is also a venture partner with Hatteras Venture Partners and managing partner of Personalized Science, LLC, a diagnostic consulting company that she founded in 2008. Board-certified in both anatomic and clinical pathology, she received her medical degree from Columbia University College of Physicians and Surgeons.

“We are excited and honored to have Myla join the board of Akoya as the company embarks on a new phase of growth,” said Brian McKelligon, the CEO of Akoya Biosciences. “Myla is an established leader and visionary in the life sciences and diagnostics markets. Her experience leading organizations in all phases of diagnostic testing, from discovery to development and commercialization, will help Akoya achieve its ultimate goal of improving patients’ lives.”

About Akoya Biosciences

As The Spatial Biology Company^®, Akoya Biosciences’ mission is to bring context to the world of biology and human health through the power of spatial phenotyping. The company offers comprehensive single-cell imaging solutions that allow researchers to phenotype cells with spatial context and visualize how they organize and interact to influence disease progression and treatment response. Akoya offers two distinct solutions, the CODEX^® and Phenoptics™ platforms, to serve the diverse needs of researchers across discovery, translational and clinical research. To learn more about Akoya, visit www.akoyabio.com.

Cautionary Note Regarding Forward Looking Statements

This press release contains “forward-looking statements” under applicable securities laws. In some cases, such statements can be identified by words such as: “may,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “ongoing” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. Forward-looking statements include express or implied statements regarding our ability to achieve our business strategies, growth, or other future events or conditions. Such statements are based on our current beliefs, expectations, and assumptions about future events or conditions, which are subject to inherent risks and uncertainties, including the risks and uncertainties discussed in the filings we make from time to time with the Securities and Exchange Commission. Actual results may differ materially from those indicated in forward-looking statements, and you should not place undue reliance on them. All statements herein are based only on information currently available to us and speak only as of the date hereof. Except as required by law, we undertake no obligation to update any such statement.

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/c9e7c63d-6047-47ab-bf73-f9f676762989

Investor Contact:

Priyam Shah
Akoya Biosciences
[email protected]

Media Contact:
Michelle Linn
Bioscribe, Inc.
774-696-3803
[email protected]